HAVEL'S

Primary DI
B070B65CN1
Brand
HAVEL'S
Company
Havel's Incorporated
Model
SUT. 5-0 SILK BLK BR 18"/HS-16
Catalog number
B65CN
Published
2016-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAPSuture, Nonabsorbable, Silk

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAPSuture, Nonabsorbable, SilkGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B070B65CN1PackageHIBCC12In Commercial Distribution
B070B65CN0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Silk suture, sterileA sterile, natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable needle. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-638-4770RHUNLEY@HAVELS.COM

Regulatory Flags#

DUNS number
101497568
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B070A64E0HAVEL'S"SUT 3-0 PLAIN GUT 18""/HS-24"A64E2016-06-16
B070A66CH0HAVEL'S"SUT 4-0 CHROMIC GUT 27""/DS-18"A66CH2016-06-16
B070A66CR0HAVEL'S"CHROMIC GUT 3/0 27"" C6 *SUB*"A66CR2016-06-16
B070A66DL0HAVEL'S"SUT 4-0 PLAIN GUT 18""/DS-18"A66DL2016-06-16
B070A66EL0HAVEL'S"3/0 PLAIN GUT 18"" DS-18"A66EL2016-06-16
B070A68EL0HAVEL'S"SUT. 3-0 PLAIN GUT 18""/DS-24"2016-06-16
B070A77C0HAVEL'S "SUT 5-0 PLAIN GUT 18""/DS-12"A77C2016-06-16
B070A77CH0HAVEL'S"SUT. 4-0 CHROMIC GUT 18""/DS-12"A77CH2016-06-16
B070B64E0HAVEL'S"SUT. 3-0 SILK 18""/HS-24"B64E2016-06-16
B070B65CN0HAVEL'S"SUT. 5-0 SILK BLK BR 18""/HS-16"B65CN2016-06-16
B070B66D0HAVEL'S"SUT 4-0 SILK BLK 18""/DS-18"B66D2016-06-16
B070B66E0HAVEL'S"SUT. 3-0 SILK BLK 18""/DS-18"B66E2016-06-16
B070B66K0HAVEL'S"SUT. 5-0 SILK BLK 18""/DS-18"B66K2016-06-16
B070B68E0HAVEL'S"C7 3/0 BBS 18""/45 CM ON CARD"B68E2016-06-16
B070B77C0HAVEL'S"SUT 5-0 SILK BLK 18""/DS-12"B77C2016-06-16
B070B77D0HAVEL'S"SUT. 4-0 SILK BLK 18""/DS-12"B77D2016-06-16
B070BN61B0HAVEL'S"SUT 6-0 NYLON 18""/DSS-10"BN61B2016-06-16
B070BN62B0HAVEL'S "SUT 6-0 NYLON 18""/DSS-12"BN62B2016-06-16
B070BN62C0HAVEL'S"SUT.5-0 BK NYLON 18""/DSM-13"BN62C2016-06-16
B070BN62D0HAVEL'S"SUT 4-0 NYLON 18""/DSS-12"BN62D2016-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07757093028192SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028222SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028260SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028536SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028734SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028833SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028888SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028956SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028987SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029014SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029236SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029366SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029373SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029427SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029489SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029502SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029540SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029564SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029595SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029601SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093218463SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029809SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029854SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029878SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029892SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030027SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030089SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030256SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030294SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030331SUTUMEDUnilene S.A.C.GAP2023-01-06